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TGA advice

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Advice from the Therapeutic Goods Administration, listed in date order (most recent first).

Updating medicine ingredient names  (member only content)

The Therapeutic Good Administration (TGA) has advised that from April 2016 it will be updating some medicine ingredient names used in Australia to align with names used internationally. The list below shows the medicine ingredient names that will be changing.  To find the new name where there is to be a change, simply begin typing the name of the ingredient into the search box.

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TGA safety advisory - Bull's Genital Tablets

26 May 2014  The TGA has warned consumers that Bull's Genital tablets, sold online and which contain  the undeclared substances sildenafil and chloramphenicol, pose a serious risk to health and should not be taken.
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Recall - syringe dosing device for Children’s Panadol

RC-2013-RN-01086-1 GlaxoSmithKline (GSK) is initiating a recall of Children’s Panadol Baby Drops Syringe due to possible inaccurate placement of the dosing indicator on the syringe.

Amoxil paediatric drops

In response to members inquiries PSA has approached Aspen for clarification on the correct instructions for mixing Amoxil paediatric drops.
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Ventolin and Asmol (salbutamol) CFC-free MDI 100 mcg/200 doses inhalers (certain batches only)

GlaxoSmithKline (GSK) and Alphapharm, in consultation with the Therapeutic Goods Administration, are undertaking a voluntary recall of several batches of Ventolin and Asmol inhalers due to a fault in the delivery mechanism of a small number of inhalers within each batch. This can lead to less than the full dose being delivered for each puff.

The only batches affected are as follows:

  • Ventolin Batch numbers KN7170, KN7173, KN7178, and KN7179
  • Asmol Batch Numbers KL6790, KL6795, KL6796, KL6797, KL6798, and KL6799

The recall notice is published on the Therapeutic Goods Administration website at http://www.tga.gov.au/safety/alerts-medicine-ventolin-asmol-121224.htm


TGA advice - cough and cold medicines for children

TGA advises of new requirements for OTC cough and cold medicines for children effective from 1 September 2012:

  • These medicines should not be given to children under six years of age; and
  • If they are indicated for children six to 11 years, they should only be given on the advice of a doctor, pharmacist or nurse practitioner.

Please note:

  • There are no scheduling changes to these products.
  • There will be products with existing labels as well as products with new labels in the marketplace. There is no plan to recall products with the existing labels and they may remain in the market until they reach their expiry date.
  • New products will have child-resistant packaging.

Information for pharmacy staff: Changes to the use of cough and cold medicines in children

PSA has developed a fact sheet detailing the affected products, with scenarios to assist pharmacists with communicating this information to patients. Page 1 of the factsheet can be printed and kept in the pharmacy to help you explain these changes when counselling patients.

If you are a PSA member but cannot see a link to the factsheet below, you need to log in first.

Cough-and-cold-medicines-for-children-factsheet-sept-2012 (388.8 KiB)


This item is listed in the following categories: • Guidelines


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